Primary outcome
What 1966 measured first
| Measure | Liraglutiden=26 | Placebon=20 |
|---|---|---|
| week 0 | 7.92(0.15) | 7.48(0.18) |
| week 52 | 7.45(0.12) | 7.58(0.14) |
Phase 3 · Liraglutide
1966 trial results
Liraglutide in Type 1 Diabetes
- Participants
- 69
- Status
- completed
- Completed
- 2019-07-29
- Sponsor
- University at Buffalo
As posted on ClinicalTrials.gov (NCT01722240), updated at source Jan 23, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Secondary outcomes
What else it measured
| Measure | Liraglutiden=26 | Placebon=20 |
|---|---|---|
| week 0 | 173(5) | 160(6) |
| week 52 | 156(6) | 156(6) |
| Measure | Liraglutiden=26 | Placebon=20 |
|---|---|---|
| week 0 | 83.6(3.8) | 84.1(4.0) |
| week 52 | 80.5(3.8) | 83.8(4.0) |
The trial
How 1966 was run
The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.
- Liraglutide 1.8mg: Daily Injection
- Placebo: Daily Injection
Who could join the trial
Inclusion Criteria: 1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2. Regularly measuring blood sugars four times daily. 3. HbA1c of less than 8.5%. 4. Well versed with carbohydrate counting. 5. Age 18-75 years. 6. BMI 20-40 kg/m2 Exclusion Criteria: 1. Type 1 diabetes for less than 6 months; 2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3. Hepatic disease (transaminase \> 3 times normal) or cirrhosis; 4. Renal impairment (serum eGFR \< 30ml/min/1.73m2); 5. HIV or Hepatitis B or C positive status; 6. Participation in any other concurrent clinical trial; 7. Any other life-threatening, non-cardiac disease; 8. Use of an investigational agent or therapeutic regimen within 30 days of study. 9. history of pancreatitis 10. pregnancy 11. inability to give informed consent 12. history of gastroparesis 13. history of medullary thyroid carcinoma or MEN 2 syndrome.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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